Recall Z-0903-2021 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
| Date | Jan 22, 2021 (initiated Nov 2, 2020) |
| Status | Open, Classified |
| Reason | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. |
| Root cause | Device Design |
| Action | On 11/02/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the V60 Ventilators may experience two potential issues with the navigation ring interface (see table below for additional information). 1. The navigation ring may become inoperative or begin operating intermittently. 2. The navigation ring may not behave as expected, making it difficult for the user to change ventilator settings via the touchscreen. and if clinicians accept an incorrect setting and leaves the patient on the ventilator without responding to the resu |
| Quantity | 9,856 systems (Amended on 07/29/2021 - 5 U.S. systems for faceplate replacement) |
| Distribution | Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Den |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |